Status:
COMPLETED
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
Brief Summary
The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 week...
Eligibility Criteria
Inclusion
- Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline
Exclusion
- Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
- Patient with complications that will impair the judgment of efficacy of this drug
- Patient with convulsive disorders such as epilepsy or such a history
- Patient with liver disease, renal impairment, heart disease or such other complication
Key Trial Info
Start Date :
September 25 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2004
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00446056
Start Date
September 25 2003
End Date
June 16 2004
Last Update
August 15 2024
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